Global Assessment Of Disease Activity Research Articles

Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis.

BackgroundIn the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients’ and parents’ quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data.ObjectiveThe aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses.MethodsThis is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases.ResultsA total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001).ConclusionsAn electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system.

Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON)

ObjectivesTo assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or...

A proof-of-concept study with the tyrosine kinase inhibitor nilotinib in spondyloarthritis.

BackgroundTo evaluate the immunomodulating and clinical effects of nilotinib, a tyrosine kinase inhibitor, in a proof-of-concept study in spondyloarthritis (SpA) assessing the mast cell as potential novel therapeutic target in this disease.MethodsTwenty eight patients with active peripheral (pSpA) and/or axial SpA (axSpA) were included in a randomized, double-blind, placebo-controlled clinical trial (Trial registration: Trialregister.nl NTR2834). Patients were treated 1:1 with nilotinib or placebo for 12 weeks, followed by an open label extension for another 12 weeks. Paired synovial tissue biopsies, serum sampling and assessment of clinical symptoms were performed serially.ResultsIn pSpA (n = 13) synovial inflammation appeared to diminish after 12 weeks of nilotinib treatment as evidenced by histopathology (decrease in number of infiltrating CD68+ and CD163+ macrophages and mast cells). Compared to placebo mRNA expression of c-Kit as mast cell marker (p = 0.037) and of pro-inflammatory cytokines such as IL-6 (p = 0.024) were reduced. The reduction of synovial inflammation was paralleled by a decrease in serum biomarkers of inflammation such as C-reactive protein (p = 0.024) and calprotectin (p = 0.055). Also clinical parameters such as patient’s global assessment of disease activity (p = 0.031) and ankylosing spondylitis disease activity score (p = 0.031) showed improvement upon 12 weeks of nilotinib but not placebo treatment. This improvement was further augmented at week 24. In contrast to pSpA, neither serum biomarkers of inflammation nor clinical parameters improved upon nilotinib treatment in axSpA. During the trial one serious adverse event occurred, which was considered unrelated to the study drug.ConclusionsThis small proof-of-concept study suggests that nilotinib treatment modulates inflammation and clinical symptoms in pSpA. A similar effect was not seen in axSpA. Trial registration: trialregister.nl registration code NTR2834 registered 31 March 2011

Impact of intensive treatment and remission on health-related quality of life in early and established rheumatoid arthritis

ObjectivesTo establish if using intensive treatment to reduce synovitis and attain remission in active rheumatoid arthritis (RA) improves all aspects of health-related quality of life (HRQoL).MethodsA secondary analysis of two...

Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial.

BackgroundAnkylosing spondylitis (AS) is a chronic inflammatory autoimmune disease. Kunxian capsule, a Chinese patent medicine which has been used in the treatment of immunologic diseases for many years in China, has anti-inflammatory and immunoregulatory effects. This study investigates the efficacy and safety of Kunxian capsules in the treatment of AS.MethodThis was a randomized, double-blind, parallel control clinical trial involving 80 patients with AS who fulfilled the modified New York criteria (1984) and had active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥40 mm under background stable nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 4 weeks. Patients were randomly divided into two groups, the Kunxian group and the placebo group, and Kunxian (0.6 g, three times per day) and the placebo were provided for 12 weeks. The primary endpoint was the Assessment of SpondyloArthritis international Society (ASAS) 20 response rate at week 12. The secondary endpoints were ASAS 40, BASDAI 50, the Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and Ankylosing Spondylitis Disease Activity Score on the basis of C-reactive protein level (ASDAS-CRP) at weeks 2, 6, and 12.ResultsThe primary endpoint of ASAS 20 at week 12 was achieved in 13 of 35 patients (37.1 %) among the Kunxian group, compared with 4 of 33 (12.1 %) in the placebo group (p < 0.05). Significant improvement (BASDAI 50) was also observed between the Kunxian group and the placebo group at week 6 (14 (40 %) and 5 (15.5 %), respectively, p < 0.05). At weeks 2, 6, and 12, the ASDAS-CRP level of the Kunxian group was significantly lower than that of the placebo group, especially at week 6 (p < 0.01). Kunxian obviously reduced CRP levels compared to placebo at weeks 2, 6, and 12 (p < 0.05). Compared with the placebo, Kunxian was associated with greater improvements in signs and symptoms of patients with AS from the baseline to week 12, and significant intergroup differences of additional composite indices of disease activity (i.e., erythrocyte sedimentation rate, patient global assessment of disease activity, total back pain, level of morning stiffness, tender joints, and BASFI scores) were also observed.ConclusionKunxian capsule significantly decreased the disease activity of patients with AS.Trial registrationNCT00953979. Registered on 5 August 2009.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1438-6) contains supplementary material, which is available to authorized users.

Patient-preference disability assessment for disabling knee osteoarthritis: Validity and responsiveness of the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire

BackgroundThe McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) measurement of function may be more comprehensive and add useful information about disability than traditional fixed-item questionnaires, especially about issues that really matter to the patient, for developing personalized medicine. ObjectivesWe aimed to assess priorities in disability and restriction in participation in patients with disabling knee osteoarthritis (OA) by the MACTAR and evaluate its validity and responsiveness. MethodsWe evaluated 127 in- and outpatients with knee OA in two tertiary care teaching hospitals between August 2010 and July 2012 by using the MACTAR, the Western Ontario and McMaster Universities Osteoarthritis Index, Lequesne scale, Fear Avoidance Beliefs Questionnaire, a life satisfaction score and pain, global assessment of disease activity and functional impairment scores on a numerical rating scale. Validity was assessed by Pearson correlation and responsiveness by the standardized response mean (SRM) and effect size (ES). ResultsPatients ranked 35 different activities by the MACTAR; the 3 domains of the International Classification of Functioning, Disability and Health most often identified were mobility (cited 233 times, 52.3%); community, social and civic life (cited 122 times, 27.4%); and domestic life (cited 64 times, 14.4%). The MACTAR score was best correlated with functional impairment (r=0.5). Convergent and divergent validity was as expected. In all, 108 patients completed a 6-month follow-up evaluation: 27 patients shifted their priorities at 6 months, for a decrease in SRM and ES. The SRM (0.64) and ES (0.92) for the MACTAR without shifts in priorities were the highest among the outcome measures tested; for patients considering their condition improved, the values were 0.85 and 1.17, respectively. ConclusionsFor assessing priorities in disability and restriction in participation among patients with knee OA, the MACTAR has acceptable validity and responsiveness.

The association of clinical parameters and ultrasound verified inflammation with patients' and physicians' global assessments in psoriatic arthritis.

To study the association of clinical and/or ultrasound variables with patients' (PGA) and physicians' (EGA) global assessment of disease activity in psoriatic arthritis (PsA). The correlation of these parameters with the discordance between PGA and EGA, as well as with PGA/EGA changes over 6 months was also investigated. Prospective study of 83 consecutive PsA patients with 2 visits scheduled 6 months apart. All patients underwent the following assessments: tender (TJC) and swollen joint count (SJC), PASI, dactylitis and Leeds enthesitis index. PGA, patients' level of pain (pain VAS), EGA, and HAQ were also recorded. Grey scale (GS) and power Doppler (PD) ultrasound were performed at 68 joints (evaluating synovia and tendons) and 14 entheses. Regression analyses were performed to assess the association of these variables with PGA and EGA. Two new variables "PGAminusEGA" and "PGAchange - EGAchange" were developed to explore the discrepancy between PGA and EGA and the consistency of PGA/EGA changes over time, respectively. The parameters explaining most of PGA and EGA variability were pain VAS (30.5%) and SJC (48.5%), respectively. The correlation between EGA and joint counts was stronger in patients with high vs. low levels of ultrasound verified inflammation. PGAminusEGA was mainly explained by pain and SJC. Pain was the most important predictor of PGA change whereas TJC and HAQ were more closely associated with EGA changes. "PGAchange-EGAchange" was linked to pain and SJC. Ultrasound scores were not linked with either of these variables. Pain VAS and joint counts are the most important clinical parameters explaining patients' and physicians' perception of disease activity, whereas the correlation of active inflammation as verified by sonography with these factors is limited.

What factors affect discordance between physicians and patients in the global assessment of disease activity in rheumatoid arthritis?

Objective: To identify the level of agreement between patients with rheumatoid arthritis (RA) and physicians in the global assessment of disease activity and to explore factors influencing their discordance.Methods: A total of 4368 patients with RA were analyzed from the KORean Observational study Network for Arthritis (KORONA) database. Patients were divided into four subgroups according to difference from their physicians in the assessment of disease activity by substracting physician’s visual analog scale (VAS) from patient’s VAS as follows: positive discordance group I (10 mm ≤ discordance <25 mm), positive discordance group II (≥25 mm), concordance (<|10| mm), and negative discordance (≤ −10mm). Multinomial logistic regression analysis was performed to identify factors associated with discordance.Results: Only 1350 (29.2%) patients were classified in the concordance group. Positive discordance was found in 52.3% of the patients (n = 2425), with 33.7% (n = 1563) showing marked discordance (≥25 mm). The high disease activity (OR =1.41), gastrointestinal (GI) disease (OR =1.28), pain (OR =1.12), fatigue (OR =1.07) were consistently associated with positive discordance.Conclusion: More than half of patients with RA thought their disease more severe than their physicians. In addition to high disease activity, pain, fatigue, and sleep disturbance or GI disease were associated with the discordance between physicians and patients with RA.

The Challenge and Opportunity of Capturing Patient Reported Measures of Rheumatoid Arthritis Disease Activity in Vulnerable Populations with Limited Health Literacy and Limited English Proficiency.

Limited health literacy and limited English proficiency are widely prevalent and contribute to rheumatoid arthritis (RA) health care disparities. The RA Patient Global Assessment of Disease Activity often introduces complexity to the health care encounters of patients and research subjects with limited health literacy and limited English proficiency. Important work is being done to ensure that patient-reported outcomes are validated and appropriate for diverse and vulnerable populations.

Development of Preliminary Remission Criteria for Gout Using Delphi and 1000Minds Consensus Exercises.

To establish consensus for potential remission criteria to use in clinical trials of gout. Experts (n = 88) in gout from multiple countries were invited to participate in a web-based questionnaire study. Three rounds of Delphi consensus exercises were conducted using SurveyMonkey, followed by a discrete-choice experiment using 1000Minds software. The exercises focused on identifying domains, definitions for each domain, and the timeframe over which remission should be defined. There were 49 respondents (56% response) to the initial survey, with subsequent response rates ranging from 57% to 90%. Consensus was reached for the inclusion of serum urate (98% agreement), flares (96%), tophi (92%), pain (83%), and patient global assessment of disease activity (93%) as measurement domains in remission criteria. Consensus was also reached for domain definitions, including serum urate (<0.36 mm), pain (<2 on a 10-point scale), and patient global assessment (<2 on a 10-point scale), all of which should be measured at least twice over a set time interval. Consensus was not achieved in the Delphi exercise for the timeframe for remission, with equal responses for 6 months (51%) and 1 year (49%). In the discrete-choice experiment, there was a preference towards 12 months as a timeframe for remission. These consensus exercises have identified domains and provisional definitions for gout remission criteria. Based on the results of these exercises, preliminary remission criteria are proposed with domains of serum urate, acute flares, tophus, pain, and patient global assessment. These preliminary criteria now require testing in clinical data sets.

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis

ObjectivesTo describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world.Setting46 primary...

Assessment of Fatigue in Spondyloarthritis and Its Association with Disease Activity.

To evaluate fatigue in patients with spondyloarthritis (SpA) and to define its association with disease-related factors and patients' features. A cross-sectional multicenter study which includes 2251 patients with SpA selected from the national Spondyloarthropathies Registry (the Spanish Society of Rheumatology; REGISPONSER) Spanish cohort. The primary outcome was the assessment of fatigue performed with the first item of the Bath Ankylosing Spondyloarthritis Disease Activity Index followed by the study of its relation with different factors organized into 4 groups: sociodemographics, emotional, disease-related, and disease activity. Univariate logistic regressions, multivariate logistic regression, and multiple linear regressions were performed to relate fatigue with the studied covariates. Mean fatigue score in all patients with SpA was 4.3 ± 2.9, with statistically significant differences between different SpA types. In univariate logistic regressions, significant differences were seen for many variables included in the 4 groups. Multivariate logistic regression showed that high fatigue score was related with sex (female), emotional component, the Ankylosing Spondylitis Quality of Life score, stiffness, and high levels of 2 visual analog scale items (vertebral pain in the last week and patient's global assessment of disease activity). The multivariate linear regression showed that fatigue was mainly explained by disease-related factors and disease activity (54.1%), but sex and emotional status may also be involved in 13.5% of the variance. Fatigue is associated with disease-related factors and mostly with SpA activity. However, the emotional component and sex may contribute to the onset of fatigue.

Involvement of the multidisciplinary team and outcomes in inpatient rehabilitation among patients with inflammatory rheumatic disease.

BackgroundThe last decades have for patients with inflammatory rheumatic diseases seen a shift towards more physically active rehabilitation programs, often provided as out-patients with less use of inpatient facilities. There is little research on which effect the multidisciplinary team has on health outcomes for patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and connective tissue disease. This study examined patient reported outcomes for patients with inflammatory rheumatic diseases receiving rehabilitation care as inpatients in departments of rheumatology, and studied how number of consultations with the multidisciplinary team affected these clinical outcomes.MethodsPatients with inflammatory rheumatic diseases were included in a multi-center prospective observational study if rehabilitation was considered a focus during an inpatient stay at four departments of rheumatology. At admission, discharge, and after 3 and 6 months, 317 patients were assessed with patients reported outcomes (PRO) including health assessment questionnaire (HAQ), short-form 36 (SF-36), pain, fatigue, patient global assessment of disease activity, self-efficacy scales, rheumatoid arthritis disease activity index (RADAI), and SF-6D utility. Patients stated consultations with the multidisciplinary team.ResultsImprovements were short-lived, and at 6 months follow-up period only mental health, pain and utility remained improved with small effect sizes. Extensive involvement of health professionals was not associated with improved outcomes.ConclusionsPatients with inflammatory rheumatic disease receiving inpatient multidisciplinary rehabilitation had small and mainly short-term improvements in most PROs. High use of the multidisciplinary team did not enhance or preserve rehabilitation outcomes in inflammatory rheumatic conditions when admitted as inpatients.

RESULTS OF AN OBSERVATIONAL PROSPECTIVE STUDY OF THE EFFICACY AND SAFETY OF BELIMUMAB (BENLYSTA®) IN SYSTEMIC LUPUS ERYTHEMATOSUS IN REAL CLINICAL PRACTICE

Therapy for systemic lupus erythematosus (SLE) remains challenging. The long-term use of glucocorticoids (GC) and cytostatics considerably improves life expectancy, but at the same time favors the development of irreversible organ damages. To evaluate the efficacy of belimumab (BLM), a biological agent, that blocks B-lymphocyte-stimulating factor registered for the treatment of active SLE, is an important task of the practice of rheumatology. Objective: to evaluate the efficacy and safety of BLM in patients with high and moderate SLE activity. Subjects and methods. The investigation enrolled 16 patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score of 6 to 19, who were positive for antinuclear factor (100%) and had low complement levels and high anti-native DNA antibodies (81%). BLM was used as monthly intravenous infusions at a dose of 10 mg/kg. The efficiency and safety of the therapy were evaluated monthly and 1 year after the initiation of treatment with BLM; SLE activity was estimated using SLEDAI-2K; a physician’s global assessment of disease activity on a visual analogue scale (VAS); anti-DNA antibody level changes, complement levels, a GC dose, damage index, and adverse events were determined. Results and discussion. BLM therapy proved to be effective in 62% of cases at 1 year after therapy initiation. At 1 month, SLE activity significantly decreased with SLEDAI-2K score diminishment from 9.31±3.21 to 6.25±2.80 in the entire group (p < 0.04). Over a month, the physician’s global assessment of disease activity significantly reduced from 19.25±6.60 to 13.68±3.97 mm (р<0.01) and reached minimum (8.28±6.87 mm) by 10 months of therapy. There was a significant decrease in anti-DNA antibodies and an increase in complement C4 level at 5 and 3 months of therapy, respectively. Six of the 10 patients who had received a complete cycle of BLM therapy achieved remission at 12 months. The dose of GC was significantly reduced at 6 months of therapy. Adverse events were rare. BLM was discontinued because of its inadequate efficacy in 4 patients. Conclusion. Twelve-month therapy with BLM is effective in patients with high and moderate SLE activity according to SLEDAI-2K and with high immunological activity. The use of BLM in SLE contributes to a GC dose reduction and fails to cause serious adverse events.

Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

IntroductionThe effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined.MethodsAdults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI).ResultsEarly significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts.ConclusionsRapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits.Trial registrationClinicalTrials.gov identifier: NCT00717236. Registered on 15 July 2008.

Reliability and Validity of the Work Instability Scale for Rheumatoid Arthritis

ObjectiveThe objective was to evaluate the psychometric properties of the Rheumatoid Arthritis-Work Instability Scale (RA-WIS) in a clinical trial setting. MethodsSecondary analyses were conducted using data from a 56-week, randomized controlled trial of patients with early rheumatoid arthritis (RA). Patient-reported outcome measures included the RA-WIS, the Health Assessment Questionnaire (HAQ), the Rheumatoid Arthritis Quality of Life Questionnaire, and the Global Assessment of Disease Activity and Pain, data for which were collected at baseline and at weeks 12, 16, 24, and 56. Data were analyzed for reliability, validity, and responsiveness. ResultsAmong 148 patients whose data were analyzed, more than half were women (56.1%) with a mean age of 46.8 years. On average, patients experienced RA symptoms for 8.7 months; the mean 28-Joint Disease Activity Score (DAS28) was 5.9, and the mean HAQ – Disability Index was 1.3. The RA-WIS demonstrated excellent internal consistency and test-retest reliability (α = 0.89 and intraclass correlation coefficient = 0.91, respectively). At baseline and week 24, moderate to strong correlations were seen between RA-WIS total scores and the HAQ, the Global Assessment of Disease Activity, and the Pain Rheumatoid Arthritis Quality of Life Questionnaire, ranging from 0.47 to 0.81 (all P < 0.0001). Mean RA-WIS total scores and work disability risk levels discriminated between clinical severity scores on the DAS28, the HAQ – Disability Index, and the Physician Global Assessment of Disease Activity (all P < 0.05). Mean baseline to week 24 RA-WIS total change scores were significantly different among American College of Rheumatology responder groups (P ≤ 0.0001) and between DAS28 remission status groups (P < 0.001). ConclusionsThese findings provide evidence supporting the reliability, validity, and responsiveness of the RA-WIS for evaluating work disability in patients with RA in a clinical trial setting.

Patient-physician discordance in global assessment in early spondyloarthritis and its change over time: the DESIR cohort

ObjectiveTo assess patient-physician discordance in global assessment of disease activity in early axial spondyloarthritis (axSpA) over time and determinants of discordance.MethodsDESIR (Devenir des Spondyloarthropathies Indifférenciées Récentes) is a French, multicentre,...

Assessment of Global Disease Activity in Rheumatoid Arthritis by Patients and Physicians: Differences Across Countries in the METEOR Database.

The aim of the study was to compare the differences between patient global disease activity (PtGDA) and physician global disease activity (PhGDA) score within and across 13 countries in the METEOR (Measurement of Efficacy of Treatment in the "Era of Outcome" in Rheumatology) database. Data from METEOR were used to compare PtGDA and PhGDA, scored independently on a 100-mm visual analog scale from 0 (best possible) until 100 (worst possible), in 23,117 visits in 5709 anonymized patients during the period between 2008 and 2012. Linear mixed models were used to model mean differences between PtGDA and PhGDA in 13 countries (Brazil, Czech Republic, France, Ireland, Italy, Latvia, Mexico, the Netherlands, Pakistan, Portugal, Spain, United Kingdom, and the United States), adjusted for differences in Disease Activity Score in 28 joints (DAS28). Generalized estimating equations were used to model differences (>20 mm) between PtGDA and PhGDA score as the outcome and countries as determinants, adjusted for DAS28. Mean difference between PtGDA and PhGDA scores varied by country, from -2 mm (physician scores higher) in Mexico to +14 mm (patient scores higher) in Brazil. "Country" was a significant determinant of the difference between PtGDA and PhGDA scores, independent of differences in DAS28. With the Netherlands as reference, PtGDA and PhGDA scores for individual patients differ significantly in almost all (n = 10) countries, with the exception of France and Spain. Differences between patients' and physicians' assessment of GDA vary across the countries. Influence of country must be taken into account when interpreting discordances between the patient's and the physician's assessment of GDA in rheumatoid arthritis.

THE VALUE OF THE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE (ASDAS) IN EVALUATING DISEASE ACTIVITY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS

Aim. To evaluate the clinical value of the Ankylosing Spondylitis Disease Activity Score (ASDAS) in assessing disease activity in axial SpA patients in comparison with conventional clinical measures of disease activity in daily clinical practice. Patients and methods. Eighty-five patients with axial SpA were included in a cross-sectional study. Disease activity was assessed by Bath Ankylosing Spondylitis Disease Activity (BASDAI) score, ASDAS score with C-reactive protein (ASDAS-CRP), ASDAS score with erythrocyte sedimentation rate (ASDAS-ESR), patient’s global assessment of disease activity (PtGA), CRP and ESR, while physical function was evaluated by the Bath Ankylosing Spondylitis Functional Index (BASFI). The correlation between different markers of disease activity and functional capacity and ASDAS scores were determined. Patients were grouped into high and low disease activity states according to PtGA scores, CRP levels and BASDAI scores. We compared the discriminating ability of the two ASDAS versions and the conventional clinical measures of disease activity in differentiating between patients with high and low disease activity by using standardized mean differences and receiver operating characteristic (ROC) curve analysis. Results. ASDAS-CRP and ASDAS-ESR showed good correlation with BASDAI (r = 0.84 and 0.72, respectively), PtGA (r = 0.82 and 0.74, respectively), and BASFI (r = 0.74 and 0.70, espectively). Moderate correlations were seen between the two ASDAS versions and ESR and CRP (r ranged from 0.43 to 0.70). The ASDAS versions had higher discriminating capacities as compared to conventional patient-reported measures (BASDAI and PtGA) and objective markers of disease activity (CRP and ESR). The ASDAS-CRP performed better than ASDAS-ESR. Both ASDAS versions and BASDAI had high areas under the curve (AUC) according to PtGA and CRP levels (AUC ranged from 0.66 to 0.92, all p &lt; 0.01). The calculated cut-offs for discriminating between disease activity states in our axSpA patients were relatively similar to the Assessment of Spondyloarthritis International Society (ASAS) endorsed cut-offs. Conclusions. ASDAS versions had higher discriminating ability in patients with axSpA in terms of high and low disease activity states than conventional measures. These findings suggest that ASDAS is a valid and reliable assessment tool for axial SpA patients in daily clinical practice.

Changes in dynamic contrast-enhanced pharmacokinetic and diffusion-weighted imaging parameters reflect response to anti-TNF therapy in Crohn's disease.

To investigate the effect of tumour necrosis factor (TNF)-α antagonists on MRI dynamic contrast-enhanced (DCE) and diffusion-weighted imaging (DWI) parameters in Crohn's disease (CD). 42 patients with CD (median age 24 years; 22 females) commencing anti-TNF-α therapy with baseline and follow-up (median 51 weeks) 1.5-T MR enterography (MRE) were retrospectively identified. MRE included DCE (n = 20) and/or multi-b-value DWI (n = 17). Slope of enhancement (SoE), maximum enhancement (ME), area under the time-intensity curve (AUC), Ktrans (transfer constant), ve (fractional volume of the extravascular-extracellular space), apparent diffusion coefficient (ADC) and ADCfast/slow were derived from the most inflamed bowel segments. A physician global assessment of disease activity (remission, mild, moderate and severe) at the time of MRE was assigned, and the cohort was divided into responders and non-responders. Data were compared using Mann-Whitney U test and analysis of variance. Follow-up Ktrans, ME, SoE, AUC and ADCME changed significantly in clinical responders but not in non-responders, baseline {[median [interquartile range (IQR)]: 0.42 (0.38), 1.24 (0.52), 0.18 (0.17), 17.68 (4.70) and 1.56 mm(2) s(-1) (0.39 mm(2) s(-1)) vs follow-up [median (IQR): 0.15 (0.22), 0.50 (0.54), 0.07 (0.1), 14.73 (2.06) and 2.14 mm(2) s(-1) (0.62 mm(2) s(-1)), for responders, respectively, p = 0.006 to p = 0.037}. SoE was higher and ME and AUC lower for patients in remission than for those with severe activity [mean (standard deviation): 0.55 (0.46), 0.49 (0.28), 14.32 (1.32)] vs [0.32 (0.37), 2.21 (2.43) and 23.05 (13.66), respectively p = 0.017 to 0.033]. ADC was significantly higher for patients in remission [2.34 mm(2) s(-1) (0.67 mm(2) s(-1))] than for those with moderate [1.59 mm(2) s(-1) (0.26 mm(2) s(-1))] (p = 0.005) and severe disease [1.63 mm(2) s(-1) (0.21 mm(2) s(-1))] (p = 0.038). DCE and DWI parameters change significantly in responders to TNF-α antagonists and are significantly different according to clinically defined disease activity status. DCE and DWI parameters change significantly in responders to TNF-α antagonists in CD, suggesting an effect on bowel wall vascularity.